COT Drug Rapid Test is a lateral flow chromatographic immunoassay for the detection of Cotinine in human urine at a cut-off concentration of 200 ng/mL.
COT Drug Rapid Test
1. Product Description
Product Name: The COT Drug Rapid Test
Materials Provided: Test devices, Droppers, Package insert
Cotinine is the first-stage metabolite of nicotine, a toxic alkaloid that produces stimulation of the autonomic ganglia and central nervous system when in humans. Nicotine is a drug to which virtually every member of a tobacco-smoking society is exposed whether through direct contact or second-hand inhalation. In addition to tobacco, nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal patches and nasal sprays.
In a 24-hour urine, approximately 5% of a nicotine dose is excreted as unchanged drug with 10% as cotinine and 35% as hydroxycotinine; the concentrations of other metabolites are believed to account for less than 5%. 1 While cotinine is thought to be an inactive metabolite, it’s elimination profile is more stable than that of nicotine which is largely urine pH dependent. As a result, cotinine is considered a good biological marker for determining nicotine use. The plasma half-life of nicotine is approximately 60 minutes following inhalation or parenteral administration. Nicotine and cotinine are rapidly eliminated by the kidney; the window of detection for cotinine in urine at a cutoff level of 200 ng/mL is expected to be up to 2-3 days after nicotine use.
The COT Drug Rapid Test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Cotinine, if present in the urine specimen below 200 ng/mL, will not saturate the binding sites of antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized Cotinine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Cotinine level exceeds 200 ng/mL because it will saturate all the binding sites of anti-Cotinine antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that that proper volume of specimen has been added and membrane wicking has occurred.
4.Specimen Collection and Preparation
The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed settle to obtain a clear supernatant for testing.
Urine specimens may be stored at 2-8°C for up to 48 hours prior to assay. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.
5. Directions for Use
Allow test device, urine specimen to reach room temperature (15-30°C) prior to testing.
(1)Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
(2)Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 μL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).
(3)Wait for the colored line(s) to appear. The result should be read at 5 minutes. It is important that the background is clear before the result is read. Do not interpret the result after 10 minutes.
Positive: One line in control region(C) appears
Negative: Two lines(T and C) appear
Invalid: Control line fails to appear
7. Analytical Specificity
The following table lists compounds that are positively detected in urine by the COT Drug Rapid Test at 5 minutes.
Compound Concentration (ng/mL)
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China